Regulatory Affairs Consultants

Do you have the neccessary experience?

Due to the on going success of the Interim Management Department there is an ongoing need to recruit experienced Regulatory Affairs professionals to join the team. With all the benefits of being a Unicus employee, you will have the added advantage of working with the most well respected R&D Pharmaceutical companies in the world.

Duties

Due to the nature of Interim Management, duties for this role vary and are dependant upon client project requirements, in general though duties will include :

• Maintenance of Marketing Authorisations and licence variations and renewals
• Preparation of high quality, detailed regulatory documents using varied information sources
• Preparation and submission of regulatory applications (new submissions, renewals, variations, clinical trials etc.)
• Collecting data on regulatory intelligence
• Ensuring that project work proceeds according to agreed deadlines
• Keeping up to date with (international) legislation, guidelines and customer practices
• Maintaining quality systems
• Using information from regulations, guidelines, publications and or other sources where required

Qualifications/knowledge required

• BSc degree (or higher) in a scientific field and experience in a regulatory affairs field
• Willingness to travel to client sites
• Understanding and detailed working experience of the principles, concepts and theories governing Regulatory Affairs
• Excellent written and verbal communication skills
• Able to work to strict deadlines under pressure
• Flexible, resourceful and adaptable
• Excellent team player with the ability to work autonomously

Benefits

We offer a competitive salary and benefits package, dependent on skills and experience, along with a comprehensive training and development plan.